According to Article 53(b) of the European Patent Convention, “essential biological processes” for the production of plants and animals are excluded from patent protection.

The term “essentially biological” is somewhat unclear. Rule 26(5) EPC, which is a result of incorporating the provisions of the EU Biotechnology Directive into the EPC, states that “a process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection”.

Even though this rule serves to define the terms of Article 53(b) EPC, it is somewhat ambiguous. This was made clear during the proceedings of the Enlarged Board of Appeal (EBoA) decisions, G2/07 and G1/08. These decisions said that crossing and selection as such are not entirely natural phenomena, but processes that involve human intervention.

"If the claimed process is a process for obtaining plants based on sexual crossing and selection, then it is not patentable, irrespective of what other steps may be included in the claim."